23 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENDOCERVICAL BLOCK NEEDLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780767·LEVAMED ACTIVE ANKLE SUP SLVR L IV
ULTRAPOWER
FDA UDI
Conmed Corporation·10845854007013·ULTRAPOWER BUR, ROUND (MUSTARD) 2 MM
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112240·Tap, 6.50mm, Cannulated, Fixed Sleeve
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY
FDA 510(k)
FDA Class 2
·Radiology
IOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
HDI 5000 ULTRASOUND STANDARD SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012
audifon
FDA UDI
audifon GmbH & Co. KG·EADF021224800831217201·BTE-TRT
audifon
FDA UDI
audifon GmbH & Co. KG·EADF021224800831317201·BTE-TRT
audifon
FDA UDI
audifon GmbH & Co. KG·EADF021224800833217201·BTE-TRT
audifon
FDA UDI
audifon GmbH & Co. KG·EADF021224800832517201·BTE-TRT
BI-METRIC HIP LATERALISED FEMORAL STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·March 2, 2017
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 26, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·March 21, 2008
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900
FDA Enforcement
Class II
·Ongoing·North American Rescue LLC.·October 8, 2025